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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceASUKA AND ASUKA LONGY OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC
One Scimed Place
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS038
Date Received02/12/1996
Decision Date06/12/1996
Withdrawal Date 04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ASUKA AND ASUKA LONGY OVER-THE-WIRE PTCA CATHETERS
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